83 FR 61320 - Schedules of Controlled Substances: Placement of Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, Tetrahydrofuranyl Fentanyl, and Ocfentanil in Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 230 (November 29, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 230 (November 29, 2018)
| Page Range | 61320-61323 | |
| FR Document | 2018-26045 |
[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)] [Rules and Regulations] [Pages 61320-61323] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26045] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-490] Schedules of Controlled Substances: Placement of Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, Tetrahydrofuranyl Fentanyl, and Ocfentanil in Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration maintains the placement of the substances furanyl fentanyl [N-(1-phenethylpiperidin- 4-yl)-N-phenylfuran-2-carboxamide], 4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl fentanyl [N-(4-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide], acryl fentanyl or acryloylfentanyl [N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide], tetrahydrofuranyl fentanyl [N-(1-phenethylpiperidin-4-yl)-N- phenyltetrahydrofuran-2-carboxamide], and ocfentanil [N-(2- fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide], including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil. DATES: Effective November 29, 2018. FOR FURTHER INFORMATION CONTACT: Kathy L. Federico, Regulatory Drafting and Policy Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Legal Authority Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C. [[Page 61321]] 811(d)(1)) states that, if control of a substance is required ``by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by [section 201(a) (21 U.S.C. 811(a)] or section [202(b) (21 U.S.C. 812(b)) of the Act] and without regard to the procedures prescribed by [section 201 (a) and (b) (21 U.S.C. 811(a) and (b)].'' If a substance is added to one of the schedules of the Single Convention on Narcotic Drugs (1961), then, in accordance with article 3, paragraph 7 of the Convention, as a signatory Member State, the United States is obligated to control the substance under its national drug control legislation, the CSA. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the Drug Enforcement Administration (DEA). 28 CFR 0.100. Background On May 15, 2018, the Secretary-General of the United Nations advised the Secretary of State of the United States, that during the 61st session of the Commission on Narcotic Drugs, furanyl fentanyl, 4- fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil were added to Schedule I of the Single Convention on Narcotic Drugs (1961). This letter was prompted by a decision at the 61st session of the Commission on Narcotic Drugs in March 2018 to schedule furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil under Schedule I of the Single Convention on Narcotic Drugs. As a signatory Member State to the Single Convention on Narcotic Drugs, the United States is obligated to control furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil under its national drug control legislation, the CSA, in the schedule deemed most appropriate to carry out its international obligations. 21 U.S.C. 811(d)(1). Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, Tetrahydrofuranyl Fentanyl, and Ocfentanil On November 29, 2016, May 3, 2017, July 14, 2017, October 26, 2017, and February 1, 2018, furanyl fentanyl (81 FR 85873), 4- fluoroisobutyryl fentanyl (82 FR 20544), acryl fentanyl (82 FR 32453), tetrahydrofuranyl fentanyl (82 FR 49504), and ocfentanil (83 FR 4580), respectively, were temporarily placed in schedule I of the CSA upon finding they pose an imminent hazard to the public safety. Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil share pharmacological profiles similar to morphine, fentanyl, and other synthetic opioids. Law enforcement and public health reports demonstrate the illicit use and distribution of these substances, which are available on the internet. Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil are all abused for their opioid-like effects. Evidence suggests the pattern of abuse of these substances parallels that of heroin and prescription opioid analgesics. Because furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil can be obtained through illicit sources, information on their purity and potency are unknown; thus these substances pose a significant adverse health risk to the users. Similar to morphine and fentanyl, furanyl fentanyl, 4- fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil act as [micro]-opioid receptor agonists. Data obtained from preclinical studies (in vitro and in vivo) demonstrate that furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil produce pharmacological effects similar to fentanyl and morphine. Specifically, in a drug discrimination study in animals, a behavioral test used to determine subjective effects and pharmacological similarity between a test substance and a known drug of abuse, ocfentanil substituted fully for morphine. Additional data obtained from in vivo (in animal) studies demonstrated that furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil, similar to fentanyl and morphine, produced an analgesic effect which was attenuated by naltrexone, an opioid receptor antagonist. Since 2015, furanyl fentanyl has been encountered by law enforcement and public health officials and the adverse health effects and outcomes are demonstrated by fatal overdose cases. At the time of the temporary scheduling action for furanyl fentanyl in 2016, there were at least 128 confirmed fatalities associated with the misuse and/ or abuse of furanyl fentanyl in the United States. According to the National Forensic Laboratory Information System (NFLIS \1\) and STARLiMS \2\, there were 8,516 drug exhibits containing furanyl fentanyl since 2015. For 4-fluoroisobutyryl fentanyl, law enforcement submitted a total of 2,245 drug exhibits since 2016. The DEA has also received reports of at least 62 confirmed fatalities associated with 4- fluoroisobutyryl fentanyl at the time of the temporary order in 2017. NFLIS and STARLiMS reported a total of 2,054 drug exhibits containing acryl fentanyl since 2016. The DEA also received reports of at least 83 confirmed fatalities associated with acryl fentanyl occurring in 2016 and 2017 in the United States. For tetrahydrofuranyl fentanyl, NFLIS and STARLiMS had a total of 23 drug reports since 2015 and there were two confirmed fatalities in the United States at the time of the temporary scheduling action in 2017. There were no reports in NFLIS and STARLiMS for ocfentanil at the time of this final order. However, ocfentanil was first reported in Belgium in 2015 and the exposure resulted in one death; since then, at least two additional deaths in Belgium and Switzerland related to ocfentanil have been reported. It is likely that the prevalence of these substances in opioid-related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate these substances from fentanyl. --------------------------------------------------------------------------- \1\ The National Forensic Laboratory Information System (NFLIS) is a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by State and local forensic laboratories in the United States. NFLIS data were queried on October 24, 2018. NFLIS is still reporting data for January-July 2018 due to normal lag time in reporting. \2\ STARLiMS is a laboratory information management system that systematically collects results from drug chemistry analyses conducted by DEA laboratories. STARLiMS data were queried on October 24, 2018. --------------------------------------------------------------------------- The DEA is not aware of any claims or any medical or scientific literature suggesting that furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil have a currently accepted medical use in treatment in the United States. In addition, the Department of Health and Human Services (HHS) advised DEA, by letters dated July 8, 2016, January 17, 2017, May 2, 2017, July 14, 2017, and November 8, 2017, that there were no investigational new drug applications or approved new drug applications for furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil, respectively. The DEA requested that HHS conduct a scientific and medical evaluation and [[Page 61322]] a scheduling recommendation for furanyl fentanyl (by letter dated March 1, 2017), 4-fluoroisobutyryl fentanyl (by letter dated August 28, 2017), acryl fentanyl (by letter dated April 18, 2018), and tetrahydrofuranyl fentanyl (letter dated April 18, 2018). A request for ocfentanil had not previously been submitted. Regardless of these requests and any potential responses from HHS, the DEA is not required under 21 U.S.C. 811(d)(1) to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not required to follow the procedures prescribed by 21 U.S.C. 811(a) and (b). By letter dated June 30, 2018, the Acting Administrator advised HHS that the DEA no longer requires scientific and medical evaluations and scheduling recommendations for furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, as well as, ocfentanil, although not previously requested. The HHS recommendations were no longer required due to the placement of those substances into Schedule I of the Single Convention on Narcotic Drugs (1961) in March 2018. Therefore, consistent with the framework of 21 U.S.C. 811(d), DEA concludes that furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil have no currently accepted medical use in treatment in the United States and are most appropriately placed (as it has been since May 2017, July 2017, October 2017, November 2017, and February 2018, respectively) in schedule I of the CSA. Further, while the DEA temporarily scheduled these substances under 21 CFR 1308.11(h), a subsection reserved for the temporary listing of substances subject to emergency scheduling, this order moves these substances to 21 CFR 1308.11(b). As explained above, since control is required under the Single Convention on Narcotic Drugs (1961), the DEA will not be initiating regular rulemaking proceedings to schedule these substances pursuant to 21 U.S.C. 811(a). Conclusion In order to meet the United States' obligations under the Single Convention on Narcotic Drugs (1961) and because furanyl fentanyl, 4- fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil have no currently accepted medical use in treatment in the United States, the Acting Administrator of the Drug Enforcement Administration has determined that these substances should remain in schedule I of the Controlled Substances Act. Requirements for Handling Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil have been controlled as schedule I controlled substances since November 29, 2016, May 3, 2017, July 14, 2017, October 26, 2017, and February 1, 2018, respectively. With publication of this final order, furanyl fentanyl, 4- fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil remain subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, engagement in research, and conduct of instructional activities with, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research or conducts instructional activities with, or possesses), or who desires to handle, furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312. 2. Disposal of stocks. Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl and ocfentanil must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws. 3. Security. Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. 5. Quota. A quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 is required in order to manufacture furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil. 6. Inventory. Every DEA registrant who possesses any quantity of furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil was required to keep an inventory of all stocks of these substances on hand as of November 29, 2016, May 3, 2017, July 14, 2017, October 26, 2017, and February 1, 2018, respectively, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 7. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304 and 1312. 8. Order Forms. All DEA registrants who distribute furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305. 9. Importation and Exportation. All importation and exportation of furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. 10. Liability. Any activity involving furanyl fentanyl, 4- fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil not authorized by, or in violation of the CSA, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Executive Order 12866, 13563, and 13771, Regulatory Planning and Review, Improving Regulation and Regulatory Review, and Reducing Regulation and Controlling Regulatory Costs This action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and the principles reaffirmed in Executive Order 13563 (Improving Regulation and Regulatory Review), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). This order is not an Executive Order 13771 regulatory action. Executive Order 12988, Civil Justice Reform This action meets the applicable standards set forth in sections 3(a) and [[Page 61323]] 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132, Federalism This action does not have federalism implications warranting the application of Executive Order 13132. This action does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Administrative Procedure Act The CSA provides for an expedited scheduling action where control is required by the United States obligations under international treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is required pursuant to such international treaty, convention, or protocol, the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings or procedures otherwise required for scheduling actions. Id. To the extent that 21 U.S.C. 811(d)(1) directs that if control is required by the United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, scheduling actions shall be issued by order (as compared to scheduling pursuant to 21 U.S.C. 811(a) by rule), the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this scheduling action. In the alternative, even if this action does constitute ``rule making'' under 5 U.S.C. 551(5), this action is exempt from the notice and comment requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an action involving a foreign affairs function of the United States given that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s requirement that the United States comply with its obligations under the specified international agreements. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or any other law. As explained above, the CSA exempts this final order from notice and comment. Consequently, the RFA does not apply to this action. Paperwork Reduction Act of 1995 This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501- 3521. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Congressional Review Act This action is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This order will not result in: ``an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign based enterprises in domestic and export markets.'' However, pursuant to the CRA, the DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. 0 2. In Sec. 1308.11: 0 a. Remove from paragraph (b) introductory text the term ``(b)(34)'' and add in its place the term ``(b)(39)''; 0 b. Redesignate paragraphs (b)(57) through (b)(60) as (b)(62) through (b)(65); 0 c. Redesignate paragraphs (b)(46) through (b)(56) as (b)(50) through (b)(60); 0 d. Redesignate paragraphs (b)(32) through (b)(45) as (b)(35) through (b)(48); 0 e. Redesignate paragraphs (b)(4) through (31) as (b)(5) through (32); 0 f. Add new paragraphs (b)(4), (b)(33), (b)(34), (b)(49), and (b)(61); 0 g. Remove and reserve paragraphs (h)(5), (h)(13), (h)(14), (h)(20), and (h)(29). The revision and additions to read as follows: Sec. 1308.11 Schedule I. * * * * * (b) * * * (4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylacrylamide; other name: acryloylfentanyl) . . . 9811 * * * * * (33) 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide; other name: para- fluoroisobutyryl fentanyl) . . . 9824 (34) Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran- 2-carboxamide) . . . 9834 * * * * * (49) Ocfentanil (N-(2-fluorophenyl)-2-methoxy-N-(1- phenethylpiperidin-4-yl)acetamide) . . . 9838 * * * * * (61) Tetrahydrofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenyltetrahydrofuran-2-carboxamide) . . . 9843 * * * * * Dated: November 26, 2018. Uttam Dhillon, Acting Administrator. [FR Doc. 2018-26045 Filed 11-28-18; 8:45 am] BILLING CODE 4410-09-P
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List of Subjects in 19 CFR Part 4 transmitted by the vessel operator to the DEPARTMENT OF JUSTICE
Customs duties and inspection, Entry VRU as identified in paragraph (g) of
procedures, Repairs, Reporting and this section, so that it is received within Drug Enforcement Administration
recordkeeping requirements, Vessels. ten calendar days after arrival of the
vessel. * * * 21 CFR Part 1308
Amendments to the Regulations (f) Time limit for submitting evidence [Docket No. DEA–490]
For the reasons stated in the of cost. * * * If the entry is incomplete
preamble, part 4 of the CBP regulations when submitted, evidence to make it Schedules of Controlled Substances:
(19 CFR part 4) is amended as set forth complete must be received by the VRU Placement of Furanyl Fentanyl, 4-
below. as identified in paragraph (g) of this Fluoroisobutyryl Fentanyl, Acryl
section within 90 calendar days from Fentanyl, Tetrahydrofuranyl Fentanyl,
PART 4—VESSELS IN FOREIGN AND the date of vessel arrival. and Ocfentanil in Schedule I
DOMESTIC TRADES
* * * The VRU may grant one 30-day AGENCY: Drug Enforcement
■ 1. The general authority citation for extension of time to submit final cost Administration, Department of Justice.
part 4 and the specific authority citation evidence if a satisfactory written
ACTION: Final order.
for § 4.14 continue to read as follows: explanation of the need for an extension
is received before the expiration of the SUMMARY: With the issuance of this final
Authority: 5 U.S.C. 301; 19 U.S.C. 66,
1431, 1433, 1434, 1624, 2071 note; 46 U.S.C. original 90-day submission period. order, the Acting Administrator of the
501, 60105. * * * Questions as to whether an Drug Enforcement Administration
* * * * * extension should be granted may be maintains the placement of the
referred to the Cargo Security, Carriers substances furanyl fentanyl [N-(1-
Section 4.14 also issued under 19 U.S.C. & Restricted Merchandise Branch, Office
1466, 1498; 31 U.S.C. 9701. phenethylpiperidin-4-yl)-N-
of Trade in CBP Headquarters by the phenylfuran-2-carboxamide], 4-
* * * * * VRU. Any request for an extension fluoroisobutyryl fentanyl or para-
■ 2. Amend § 4.14 as follows: beyond a 30-day grant issued by the fluoroisobutyryl fentanyl [N-(4-
■ a. Revise the third and fifth sentences VRU must be submitted through that fluorophenyl)-N-(1-phenethylpiperidin-
of paragraph (c); unit to the Cargo Security, Carriers & 4-yl)isobutyramide], acryl fentanyl or
■ b. Revise the fourth sentence of Restricted Merchandise Branch, Office acryloylfentanyl [N-(1-
paragraph (d); of Trade, CBP Headquarters. * * * phenethylpiperidin-4-yl)-N-
■ c. Revise the fourth sentence of (g) Location and jurisdiction of vessel phenylacrylamide], tetrahydrofuranyl
paragraph (e); repair unit port of entry. The VRU, fentanyl [N-(1-phenethylpiperidin-4-yl)-
■ d. Revise the second, fourth, seventh located in New Orleans, Louisiana, N-phenyltetrahydrofuran-2-
and eighth sentences of paragraph (f); processes vessel repair entries received carboxamide], and ocfentanil [N-(2-
■ e. Revise paragraph (g); from all United States ports of arrival. fluorophenyl)-2-methoxy-N-(1-
■ f. Revise the eighth and the ninth
* * * * * phenethylpiperidin-4-yl)acetamide],
sentences of paragraph (i)(1);
■ g. Revise the fifth sentence of (i) General procedures for seeking including their isomers, esters, ethers,
paragraph (i)(2); relief—(1) Applications for relief. * * * salts, and salts of isomers, esters and
■ h. Revise the third sentence of Applications must be addressed and ethers, in schedule I of the Controlled
paragraph (i)(4). submitted by the vessel operator to the Substances Act. This scheduling action
The revisions read as follows: VRU and will be decided in that unit. discharges the United States obligations
The VRU may seek the advice of the under the Single Convention on
§ 4.14 Equipment purchases for, and Narcotic Drugs (1961). This action
repairs to, American vessels.
Cargo Security, Carriers & Restricted
Merchandise Branch, Office of Trade in continues to impose the regulatory
* * * * * CBP Headquarters with regard to any controls and administrative, civil, and
(c) Estimated duty deposit and bond criminal sanctions applicable to
specific item or issue which has not
requirements. * * * At the time the schedule I controlled substances on
been addressed by clear precedent.
vessel repair entry is submitted by the persons who handle (manufacture,
* * *
vessel operator to the Vessel Repair Unit distribute, import, export, engage in
(VRU) as defined in paragraph (g) of this (2) Additional evidence. * * * After a
research or conduct instructional
section, that same identifying decision is made on an Application for
activities with, or possess), or propose
information must be included on the Relief by the VRU, the applicant will be
to handle, furanyl fentanyl, 4-
entry form. * * * CBP officials at the notified of the right to protest any
fluoroisobutyryl fentanyl, acryl fentanyl,
port of arrival may consult the VRU as adverse decision.
tetrahydrofuranyl fentanyl, and
identified in paragraph (g) of this * * * * * ocfentanil.
section or the staff of the Cargo Security, (4) Administrative protest. * * * In
Carriers & Restricted Merchandise particular, the applicable protest period DATES: Effective November 29, 2018.
Branch, Office of Trade in CBP will begin on the date of the issuance of FOR FURTHER INFORMATION CONTACT:
Headquarters in setting sufficient bond the decision giving rise to the protest as Kathy L. Federico, Regulatory Drafting
amounts. * * * reflected on the relevant and Policy Section, Diversion Control
(d) Declaration required. * * * The correspondence from the VRU. Division, Drug Enforcement
CBP port of arrival receiving either a Administration; Mailing Address: 8701
* * * * *
khammond on DSK30JT082PROD with RULES
positive or negative vessel repair Morrissette Drive, Springfield, Virginia
declaration or electronic equivalent will Dated: November 21, 2018. 22152; Telephone: (202) 598–6812.
immediately forward it to the VRU as Kevin K. McAleenan, SUPPLEMENTARY INFORMATION:
identified in paragraph (g) of this Commissioner, U.S. Customs and Border
Protection. Legal Authority
section.
(e) Entry required. * * * The entry [FR Doc. 2018–25953 Filed 11–28–18; 8:45 am] Section 201(d)(1) of the Controlled
must be presented or electronically BILLING CODE 9111–14–P Substances Act (CSA) (21 U.S.C.
VerDate Sep<11>2014 15:46 Nov 28, 2018 Jkt 247001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\29NOR1.SGM 29NOR1](https://thefederalregister.org/doc/83_FR_61550/page/1.svg)
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811(d)(1)) states that, if control of a 32453), tetrahydrofuranyl fentanyl (82 Laboratory Information System
substance is required ‘‘by United States FR 49504), and ocfentanil (83 FR 4580), (NFLIS 1) and STARLiMS 2, there were
obligations under international treaties, respectively, were temporarily placed in 8,516 drug exhibits containing furanyl
conventions, or protocols in effect on schedule I of the CSA upon finding they fentanyl since 2015. For 4-
October 27, 1970, the Attorney General pose an imminent hazard to the public fluoroisobutyryl fentanyl, law
shall issue an order controlling such safety. Furanyl fentanyl, 4- enforcement submitted a total of 2,245
drug under the schedule he deems most fluoroisobutyryl fentanyl, acryl fentanyl, drug exhibits since 2016. The DEA has
appropriate to carry out such tetrahydrofuranyl fentanyl, and also received reports of at least 62
obligations, without regard to the ocfentanil share pharmacological confirmed fatalities associated with 4-
findings required by [section 201(a) (21 profiles similar to morphine, fentanyl, fluoroisobutyryl fentanyl at the time of
U.S.C. 811(a)] or section [202(b) (21 and other synthetic opioids. Law the temporary order in 2017. NFLIS and
U.S.C. 812(b)) of the Act] and without enforcement and public health reports STARLiMS reported a total of 2,054
regard to the procedures prescribed by demonstrate the illicit use and drug exhibits containing acryl fentanyl
[section 201 (a) and (b) (21 U.S.C. 811(a) distribution of these substances, which since 2016. The DEA also received
and (b)].’’ If a substance is added to one are available on the internet. Furanyl reports of at least 83 confirmed fatalities
of the schedules of the Single fentanyl, 4-fluoroisobutyryl fentanyl, associated with acryl fentanyl occurring
Convention on Narcotic Drugs (1961), acryl fentanyl, tetrahydrofuranyl in 2016 and 2017 in the United States.
then, in accordance with article 3, fentanyl, and ocfentanil are all abused For tetrahydrofuranyl fentanyl, NFLIS
paragraph 7 of the Convention, as a for their opioid-like effects. Evidence and STARLiMS had a total of 23 drug
signatory Member State, the United suggests the pattern of abuse of these reports since 2015 and there were two
States is obligated to control the substances parallels that of heroin and confirmed fatalities in the United States
substance under its national drug prescription opioid analgesics. Because at the time of the temporary scheduling
control legislation, the CSA. The furanyl fentanyl, 4-fluoroisobutyryl action in 2017. There were no reports in
Attorney General has delegated fentanyl, acryl fentanyl, NFLIS and STARLiMS for ocfentanil at
scheduling authority under 21 U.S.C. tetrahydrofuranyl fentanyl, and the time of this final order. However,
811 to the Administrator of the Drug ocfentanil can be obtained through ocfentanil was first reported in Belgium
Enforcement Administration (DEA). 28 illicit sources, information on their in 2015 and the exposure resulted in
CFR 0.100. purity and potency are unknown; thus one death; since then, at least two
these substances pose a significant additional deaths in Belgium and
Background
adverse health risk to the users. Switzerland related to ocfentanil have
On May 15, 2018, the Secretary- Similar to morphine and fentanyl, been reported. It is likely that the
General of the United Nations advised furanyl fentanyl, 4-fluoroisobutyryl prevalence of these substances in
the Secretary of State of the United fentanyl, acryl fentanyl, opioid-related emergency room
States, that during the 61st session of tetrahydrofuranyl fentanyl, and admissions and deaths is underreported
the Commission on Narcotic Drugs, ocfentanil act as m-opioid receptor as standard immunoassays may not
furanyl fentanyl, 4-fluoroisobutyryl agonists. Data obtained from preclinical differentiate these substances from
fentanyl, acryl fentanyl, studies (in vitro and in vivo) fentanyl.
tetrahydrofuranyl fentanyl, and demonstrate that furanyl fentanyl, 4- The DEA is not aware of any claims
ocfentanil were added to Schedule I of fluoroisobutyryl fentanyl, acryl fentanyl, or any medical or scientific literature
the Single Convention on Narcotic tetrahydrofuranyl fentanyl, and suggesting that furanyl fentanyl, 4-
Drugs (1961). This letter was prompted ocfentanil produce pharmacological fluoroisobutyryl fentanyl, acryl fentanyl,
by a decision at the 61st session of the effects similar to fentanyl and tetrahydrofuranyl fentanyl, and
Commission on Narcotic Drugs in morphine. Specifically, in a drug ocfentanil have a currently accepted
March 2018 to schedule furanyl discrimination study in animals, a medical use in treatment in the United
fentanyl, 4-fluoroisobutyryl fentanyl, behavioral test used to determine States. In addition, the Department of
acryl fentanyl, tetrahydrofuranyl subjective effects and pharmacological Health and Human Services (HHS)
fentanyl, and ocfentanil under Schedule similarity between a test substance and advised DEA, by letters dated July 8,
I of the Single Convention on Narcotic a known drug of abuse, ocfentanil 2016, January 17, 2017, May 2, 2017,
Drugs. As a signatory Member State to substituted fully for morphine. July 14, 2017, and November 8, 2017,
the Single Convention on Narcotic Additional data obtained from in vivo that there were no investigational new
Drugs, the United States is obligated to (in animal) studies demonstrated that drug applications or approved new drug
control furanyl fentanyl, 4- furanyl fentanyl, 4-fluoroisobutyryl applications for furanyl fentanyl, 4-
fluoroisobutyryl fentanyl, acryl fentanyl, fentanyl, acryl fentanyl, fluoroisobutyryl fentanyl, acryl fentanyl,
tetrahydrofuranyl fentanyl, and tetrahydrofuranyl fentanyl, and tetrahydrofuranyl fentanyl, and
ocfentanil under its national drug ocfentanil, similar to fentanyl and ocfentanil, respectively.
control legislation, the CSA, in the morphine, produced an analgesic effect The DEA requested that HHS conduct
schedule deemed most appropriate to which was attenuated by naltrexone, an a scientific and medical evaluation and
carry out its international obligations. opioid receptor antagonist.
21 U.S.C. 811(d)(1). Since 2015, furanyl fentanyl has been 1 The National Forensic Laboratory Information
encountered by law enforcement and System (NFLIS) is a national forensic laboratory
Furanyl Fentanyl, 4-Fluoroisobutyryl public health officials and the adverse reporting system that systematically collects results
Fentanyl, Acryl Fentanyl, health effects and outcomes are from drug chemistry analyses conducted by State
khammond on DSK30JT082PROD with RULES
Tetrahydrofuranyl Fentanyl, and and local forensic laboratories in the United States.
demonstrated by fatal overdose cases. At NFLIS data were queried on October 24, 2018.
Ocfentanil the time of the temporary scheduling NFLIS is still reporting data for January–July 2018
On November 29, 2016, May 3, 2017, action for furanyl fentanyl in 2016, there due to normal lag time in reporting.
2 STARLiMS is a laboratory information
July 14, 2017, October 26, 2017, and were at least 128 confirmed fatalities
management system that systematically collects
February 1, 2018, furanyl fentanyl (81 associated with the misuse and/or abuse results from drug chemistry analyses conducted by
FR 85873), 4-fluoroisobutyryl fentanyl of furanyl fentanyl in the United States. DEA laboratories. STARLiMS data were queried on
(82 FR 20544), acryl fentanyl (82 FR According to the National Forensic October 24, 2018.
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![Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Rules and Regulations 61323
3(b)(2) of Executive Order 12988 to that the United States comply with its ■ c. Redesignate paragraphs (b)(46)
eliminate drafting errors and ambiguity, obligations under the specified through (b)(56) as (b)(50) through
minimize litigation, provide a clear legal international agreements. (b)(60);
standard for affected conduct, and ■ d. Redesignate paragraphs (b)(32)
Regulatory Flexibility Act
promote simplification and burden through (b)(45) as (b)(35) through
reduction. The Regulatory Flexibility Act (RFA) (b)(48);
(5 U.S.C. 601–612) applies to rules that ■ e. Redesignate paragraphs (b)(4)
Executive Order 13132, Federalism are subject to notice and comment through (31) as (b)(5) through (32);
This action does not have federalism under section 553(b) of the APA or any ■ f. Add new paragraphs (b)(4), (b)(33),
implications warranting the application other law. As explained above, the CSA (b)(34), (b)(49), and (b)(61);
of Executive Order 13132. This action exempts this final order from notice and ■ g. Remove and reserve paragraphs
does not have substantial direct effects comment. Consequently, the RFA does (h)(5), (h)(13), (h)(14), (h)(20), and
on the States, on the relationship not apply to this action. (h)(29).
between the national government and The revision and additions to read as
the States, or on the distribution of Paperwork Reduction Act of 1995
follows:
power and responsibilities among the This action does not impose a new
various levels of government. collection of information requirement § 1308.11 Schedule I.
under the Paperwork Reduction Act of * * * * *
Executive Order 13175, Consultation
1995. 44 U.S.C. 3501–3521. An agency (b) * * *
and Coordination With Indian Tribal
may not conduct or sponsor, and a (4) Acryl fentanyl (N-(1-
Governments
person is not required to respond to, a phenethylpiperidin-4-yl)-N-
This action does not have tribal collection of information unless it phenylacrylamide; other name:
implications warranting the application displays a currently valid OMB control acryloylfentanyl) . . . 9811
of Executive Order 13175. The action number. * * * * *
does not have substantial direct effects (33) 4-Fluoroisobutyryl fentanyl (N-(4-
on one or more Indian tribes, on the Congressional Review Act
fluorophenyl)-N-(1-phenethylpiperidin-
relationship between the Federal This action is not a major rule as 4-yl)isobutyramide; other name: para-
government and Indian tribes, or on the defined by the Congressional Review fluoroisobutyryl fentanyl) . . . 9824
distribution of power and Act (CRA), 5 U.S.C. 804. This order will (34) Furanyl fentanyl (N-(1-
responsibilities between the Federal not result in: ‘‘an annual effect on the phenethylpiperidin-4-yl)-N-
government and Indian tribes. economy of $100,000,000 or more; a phenylfuran-2-carboxamide) . . . 9834
major increase in costs or prices for
Administrative Procedure Act * * * * *
consumers, individual industries,
The CSA provides for an expedited Federal, State, or local government (49) Ocfentanil (N-(2-fluorophenyl)-2-
scheduling action where control is agencies, or geographic regions; or methoxy-N-(1-phenethylpiperidin-4-
required by the United States significant adverse effects on yl)acetamide) . . . 9838
obligations under international treaties, competition, employment, investment, * * * * *
conventions, or protocols. 21 U.S.C. productivity, innovation, or on the (61) Tetrahydrofuranyl fentanyl (N-(1-
811(d)(1). If control is required pursuant ability of United States-based phenethylpiperidin-4-yl)-N-
to such international treaty, convention, enterprises to compete with foreign phenyltetrahydrofuran-2-carboxamide)
or protocol, the Attorney General must based enterprises in domestic and . . . 9843
issue an order controlling such drug export markets.’’ However, pursuant to * * * * *
under the schedule he deems most the CRA, the DEA has submitted a copy Dated: November 26, 2018.
appropriate to carry out such of this final order to both Houses of Uttam Dhillon,
obligations, without regard to the Congress and to the Comptroller
findings or procedures otherwise Acting Administrator.
General.
required for scheduling actions. Id. [FR Doc. 2018–26045 Filed 11–28–18; 8:45 am]
To the extent that 21 U.S.C. 811(d)(1) List of Subjects in 21 CFR Part 1308 BILLING CODE 4410–09–P
directs that if control is required by the Administrative practice and
United States obligations under procedure, Drug traffic control,
international treaties, conventions, or Reporting and recordkeeping DEPARTMENT OF HOMELAND
protocols in effect on October 27, 1970, requirements. SECURITY
scheduling actions shall be issued by For the reasons set out above, the DEA
order (as compared to scheduling amends 21 CFR part 1308 as follows: Coast Guard
pursuant to 21 U.S.C. 811(a) by rule),
the DEA believes that the notice and PART 1308—SCHEDULES OF 33 CFR Part 165
comment requirements of section 553 of CONTROLLED SUBSTANCES [Docket Number USCG–2018–0917]
the Administrative Procedure Act
(APA), 5 U.S.C. 553, do not apply to this ■ 1. The authority citation for part 1308 RIN 1625–AA11
scheduling action. In the alternative, continues to read as follows:
Regulated Navigation Area; Upper
even if this action does constitute ‘‘rule Authority: 21 U.S.C. 811, 812, 871(b),
Mississippi River, Sabula Railroad
making’’ under 5 U.S.C. 551(5), this 956(b), unless otherwise noted.
Bridge, Mile Marker 535, Sabula, IA
khammond on DSK30JT082PROD with RULES
action is exempt from the notice and ■ 2. In § 1308.11:
comment requirements of 5 U.S.C. 553 ■ a. Remove from paragraph (b) AGENCY: Coast Guard, DHS.
pursuant to 21 U.S.C. 553(a)(1) as an introductory text the term ‘‘(b)(34)’’ and ACTION: Temporary final rule.
action involving a foreign affairs add in its place the term ‘‘(b)(39)’’;
function of the United States given that ■ b. Redesignate paragraphs (b)(57) SUMMARY: The Coast Guard established
this action is being done in accordance through (b)(60) as (b)(62) through a temporary regulated navigation area
with 21 U.S.C. 811(d)(1)’s requirement (b)(65); for certain navigable waters of the
VerDate Sep<11>2014 15:46 Nov 28, 2018 Jkt 247001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\29NOR1.SGM 29NOR1](https://thefederalregister.org/doc/83_FR_61550/page/4.svg)
Document Created: 2018-11-28 23:44:21
Document Modified: 2018-11-28 23:44:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | Effective November 29, 2018. | |
| Contact | Kathy L. Federico, Regulatory Drafting and Policy Section, Diversion Control Division, Drug Enforcement | |
| FR Citation | 83 FR 61320 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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